Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis

Food Allergy Clinical Trial

Official title:

Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04462055
• Other study ID #: 19-197
• Status: Terminated
• Start date: May 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.

Description:

The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. AD patients with moderate to severe AD who are indicated for treatment with dupilumab

2. Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm

3. Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose

4. Signed Bioday informed consent from subjects

Exclusion Criteria:

1. Subjects reacting objectively to the placebo at screening.

2. Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Food Allergy
• Food Hypersensitivity

Locations

Country	Name	City	State
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy	AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have symptomatic food allergy to peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy will be included.	Each subject will undergo two oral food challenges: one at screening and one during dupilumab treatment with a treatment duration of at least 28 weeks.
Secondary	To evaluate the effect of Dupilumab on food allergy related quality of life	The food allergy related quality of life will be measured with the Food allergy Quality of Life Questionnaire adult form (FAQLQ-AF); The FAQLQ-AF assesses health-related quality of life (HRQL) and contains a total of 29 items. The total FAQLQ-AF score is the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'.	Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.
Secondary	To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies	sIgE in blood will be measured using the ImmunoCAP system (Thermofisher, Uppsala, Sweden). Levels of = 0.35 kU/L will be considered positive. Depending on the food the following will be tested: peanut: extract, Ara h 2, 6; hazelnut: extract, cor a 1, 9, 14; walnut: extract; cow's milk: extract; hen's egg: extract; soybean: extract	sIgE in blood will be measured every three months during dupilumab treatment
Secondary	To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile	For patients treated with Dupilumab left over serum is stored except as the patient objects.; Patients treated with Dupilumab asked to participate to the biobank eczema and/or biobank acute inflammation.	The basophil activation test and the measurement of biomarkers on Luminex at baseline and after at least 28 weeks of dupilumab treatment (e.g. at time of second challenge)